进行中(不再招募) NCT05904886

评估Atezolizumab及Bevacizumab联合或不联合Tiragolumab用于未经治疗的局部晚期或转移性肝细胞癌(HCC)参与者的研究(IMbrave152)

肝癌食管癌胆道癌肉瘤Phase IIIIII 期IV 期

本研究旨在评估tiragolumab(一种抗TIGIT单克隆抗体)联合atezolizumab及bevacizumab作为第一线治疗,在不可切除、局部晚期或转移性HCC参与者中的疗效及安全性。 根据修订版本5,在申办方发出备忘录后,接受atezolizumab加bevacizumab加tiragolumab组治疗的参与者建议停

适应症:Hepatocellular Carcinoma

入组条件

纳入标准

  • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
  • Disease that is not amenable to curative surgical and/or locoregional therapies
  • No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC-measurable disease according to RECIST v1.1
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1 within 7 days prior to randomization
  • Child-pugh Class A within 7 days prior to randomization
  • Adequate hematologic and end-organ function
  • Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
  • Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo.

排除标准

  • Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
  • Treatment with systemic immunostimulatory agents
  • Treatment with systemic immunosuppressive medication
  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
  • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
  • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Acute epstein-barr virus (EBV) infection or known or suspected chronic active EBV infection
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。